MAUDE Adverse Event Report: AUTOSOFT XC; INSET I 2-PACK 60/6 GREY TCAP

Lot Number 6002766

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that on (b)(6) 2024, the patient's infusion set's tubing was detached from the connector and this issue occurred with one infusion set.Therefore, the patient's blood glucose level was 220 mg/dl.Further, they replaced the infusion set and the insulin was resumed successfully.No further information available.

• Brand Name: AUTOSOFT XC
• Type of Device: INSET I 2-PACK 60/6 GREY TCAP
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18847002
• MDR Text Key: 337694512
• Report Number: 3003442380-2024-00171
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244026001
• UDI-Public: 05705244026001
• Combination Product (y/n): N
• PMA/PMN Number: K032854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 6002766
• Date Manufacturer Received: 02/09/2024
• Patient Sequence Number: 1